Device Classification Name |
Oximeter
|
510(k) Number |
K191574 |
Device Name |
OxSAT 100 |
Applicant |
S.L.P. Ltd. |
62 Anilewicz Street |
Tel-Aviv,
IL
67060
|
|
Applicant Contact |
Avi Yosef |
Correspondent |
S.L.P. Ltd. c/o ProMedic, LLC |
131 Bay Point Dr. NE. |
St Petersburg,
FL
67060
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/14/2019 |
Decision Date | 04/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|